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NEW THIS SATURDAY: QUADRIVALENT VERSUS TRIVALENT FLU VACCINES IN CHILDREN AGED 3 TO 17 YEARS

Thursday, 16th of May 2013

• A RANDOMIZED TRIAL OF CANDIDATE INACTIVATED QUADRIVALENT INFLUENZA VACCINE VERSUS TRIVALENT INFLUENZA VACCINES IN CHILDREN AGED 3–17 YEARS

Journal of Infectious Diseasesjid.oxfordjournals.org

J Infect Dis. (2013) 207 (12): 1878-1887. doi: 10.1093/infdis/jit091 First published online: March 7, 2013

Joseph B. Domachowske1,

Heidemarie Pankow-Culot2,

Milagros Bautista3,

Yang Feng4,

Carine Claeys4,

Mathieu Peeters4,

Bruce L. Innis5 and

Varsha Jain5

- Author Affiliations

1Department of Pediatrics, Golisano Childrens Hospital, Upstate Medical University, Syracuse, New York

2Pediatric Office, Heiligenhaus, Germany

3University of the East Ramon Magsaysay Memorial Medical Center Inc., Quezon City, Philippines

4GlaxoSmithKline Vaccines, Wavre, Belgium

5GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania

Correspondence: Joseph Domachowske, MD, Upstate Medical University, Department of Pediatrics, 750 E Adams St, Syracuse, NY 13210 (domachoj@upstate.edu).

Abstract below; full text is at http://jid.oxfordjournals.org/content/207/12/1878.full.pdf+html

Background. Two antigenically distinct influenza B lineages have cocirculated since 2001, yet trivalent influenza vaccines (TIVs) contain 1 influenza B antigen, meaning lineage mismatch with the vaccine is frequent. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages vs TIV in healthy children aged 3–17 years.

Methods. Children were randomized 1:1:1 to receive QIV or 1 of 2 TIVs (either B/Victoria or B/Yamagata lineage; N = 2738). Hemagglutination-inhibition assays were performed 28 days after 1 or 2 doses in primed and unprimed children, respectively. Immunological noninferiority of QIV vs TIV against shared strains, and superiority against alternate-lineage B strains was based on geometric mean titers (GMTs) and seroconversion rates. Reactogenicity and safety were also assessed (Clinicaltrials.gov NCT01196988).

Results. Noninferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV vs TIV. QIV was highly immunogenic; seroconversion rates were 91.4%, 72.3%, 70.0%, and 72.5% against A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV.

Conclusions. QIV vs TIV showed superior immunogenicity for the additional B strain without interfering with immune responses to shared strains. QIV may offer improved protection against influenza B in children compared with current trivalent vaccines.